Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8858MA | OT |
patient was given 2 doses of FLUZONE NP within 1 month with no reported adverse event; Initial information received on 19-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 years old male patient who was administered with 2 doses of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] within 1 month with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List of concomitant vaccines: No other vaccines On 15-Oct-2025, the patient received 0.5 ml of dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-Jun-2026 and lot UT8858MA) via intramuscular route in the deltoid NOS (not otherwise specified) for Influenza (Influenza immunization). On 19-Nov-2025 the patient received 0.5 ml of dose 2 of the same vaccine (expiry date- 30-Jun-2026 and lot UT8858MA) via intramuscular route in the deltoid NOS for Influenza (Influenza immunization) within 1 month with no reported adverse event (extra dose administered) (latency- same day). It was reported that, "Treatment: None, patient is currently fine." Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.